Events

Recall of Device Recall hypo/hyperthermia system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MEDIVANCE INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    30896
  • Event Risk Class
    Class 2
  • Event Number
    Z-0436-05
  • Event Initiated Date
    2005-01-05
  • Event Date Posted
    2005-01-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-03-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36779
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, Thermal Regulating - Product Code DWJ
  • Reason
    Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.
  • Action
    US customers were notified by telephone on 1/5-6/2005, followed by letter confirmation.

Device

Device Recall hypo/hyperthermia system
  • Model / Serial
    Catalog No. 2000-02 (115 volt) and 2000-03 (230 volt) Serial numbers 3001 thru 3080
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, AZ, CO, DC, FL, GA, IA, IN, KS, MA, MD, MI, MO, NC, NY, OH, PA, TX, VA, WA. No government or military distribution. Foreign distribution to Austria, Belgium, Canada, Germany, Japan, Netherlands, Norway, Scotland.
  • Product Description
    Arctic Sun Temperature Management System
  • Manufacturer
    MEDIVANCE INC.

Manufacturer

MEDIVANCE INC.
  • Manufacturer Address
    MEDIVANCE INC., 1172 W Century Dr Ste 240, Louisville CO 80027-1681
  • Source
    USFDA